The following data is part of a premarket notification filed by Chongqing Jinshan Science & Technology Co., Ltd. with the FDA for Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series.
| Device ID | K210618 |
| 510k Number | K210618 |
| Device Name: | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Chongqing Jinshan Science & Technology Co., Ltd. Yubei District No.18 Ningshang Avenue Jinshan International Industrial City Chongqing, CN 400000 |
| Contact | Qing Xu |
| Correspondent | Qing Xu Chongqing Jinshan Science & Technology Co., Ltd. Yubei District No.18 Ningshang Avenue Jinshan International Industrial City Chongqing, CN 400000 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06946332803145 | K210618 | 000 |
| 06946332803749 | K210618 | 000 |
| 06946332803732 | K210618 | 000 |
| 06946332803718 | K210618 | 000 |